CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Code Ac: Attenuation Correction System For Dual-head Variable-angle Gamma Camera With Coincidence Option (code).

Pre-market Notification Details

Device IDK994167
510k NumberK994167
Device Name:CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel,  IL 30200
ContactDan Laor
CorrespondentDan Laor
GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel,  IL 30200
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-09
Decision Date2000-03-07
Summary:summary

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